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Average Approval Time (Months)
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0 88 89 90 91 92 93 94 95 96 97 98 99 00 01
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FIGURE 1.4 Average FDA approval times for new drugs for the years 1988
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through 2001.
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Source: FDA
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physician education are lost, and the company s image may be tarnished as well. For example, Troglitazone (Rezulin by Parke-Davis/WarnerLambert), which was initially embraced by physicians and patients alike as an effective oral antidiabetic was recalled from the market by the FDA in 2000 during Phase IV trials. Even though the drug won fast track FDA approval, it was associated with severe liver failure, which resulted in the death of some patients. Several methods can be used to extend the patent protection awarded to a pharmaceutical company for a drug, including identifying new therapeutic indications for a drug previously approved for another purpose. For example, a drug initially developed to treat heart disease may have a side effect of new hair growth noted in Phase IV clinical tri als. The pharmaceutical company may take the drug through a second drug development process, seeking FDA approval to market the drug as a hair replacement therapy. The FDA approval process doesn t cover uses that are off-label, or not expressly stipulated in the drug package insert and in information given to health care providers. For example, consider the fen-phen debacle,
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in which Pondimin (fen uramine) or Redux (dexfen uramine) were mixed with phentermine to create a potent diet cocktail. Even though each drug was separately approved by the FDA for marketing and the cocktail was effective in weight loss, it also caused primary pulmonary hypertension and heart valve damage. As a result, Wyeth-Ayerst Laboratories, which marketed the antiobesity drugs, was encouraged to voluntarily with draw the drugs from the market at the request of the FDA. The promise of biotechnology is in signi cantly decreasing a candi date drug s time to market and in minimizing the likelihood of adverse reactions and a recall in Phase IV clinical trials. A shortened time to market can be worth hundreds of millions of dollars by extending the time a drug is on the market before the patent protection expires, and a Phase IV recall can be nancially devastating, even for a multinational pharmaceutical company. One approach to decreasing development time is to use rational drug design, in which the drug discovery and screening phases of the drug de velopment process are compressed to months instead of years. Instead of randomly hunting for drugs that may affect a speci c type of cancer cell, for example, researchers use computer modeling to determine the molecu lar structure of the drug that will most likely interfere with the metabo lism of the cancer. Once the structure of the needed drug is determined, the drug can be synthesized in the laboratory. An alternate approach, combinatorial drug design, relies on biotech methods to quickly and inex pensively create expansive libraries of novel synthetic compounds that serve as candidate drugs. It s important to note that while these technolo gies may eventually shorten the screening time from a year or more to days or weeks, there aren t yet any well-known drugs on the market that owe their existence to combinatorial chemistry or rational drug design. There are, however, several drugs developed using these technologies while they were coming to market. A challenge for the pharmaceutical industry is to develop rational and combinatorial drug design to the point that the return on investment in computer modeling software and hardware and in creating and maintain ing libraries of candidate drugs are economically viable alternatives to tra ditional approaches. The pressure on pharmaceutical rms to develop new approaches to drug development is enormous, given that the number of drugs on patent is shrinking, as is number of new applications to the FDA for regulatory approval. Furthermore, although research and development expenditures have increased several-fold since the early 1980s, the number of drugs approved for the market hasn t increased in proportion to the in vestment. Proponents of the biotech industry contend that the best way for the pharmaceutical industry to survive and thrive is to industrialize molec ular biology through computer and mass production technologies.
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